BioMarin Pharmaceutical Inc.
San Rafael, CA, United States
Entry Level, Pharmaceutical, Sciences
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives. SUMMARYThis is an entry-level position within the clinical/nonclinical regulatory affairs group. This position will support designated regional regulatory activities for assigned projects and be responsible for coordinating the preparation and execution of submissions to regulatory authorities.RESPONSIBILITIESResponsible for preparing regulatory submissions for investigational and commercial products including IND/CTAs, protocol and information amendments, new investigator amendments, IND Annual ReportsPerforms workflows and procedures regarding document tracking, retrieving, and disseminating information.Works to develop and acquire required regulatory skills and knowledge, with mentorship from immediate manager.Seeks assistance from appropriate internal and external resourcesKNOWLEDGE AND SKILLS1-2yrs experience in Regulatory Affairs or equivalent experience in a related function.Basic understanding of the role of Regulatory AffairsGood organization skills and ability to work on several activities in alignment with timeline.Strong interpersonal and communication (written and verbal) skillsAbility to travel as needed for interactions with Health Authorities or as determined by the businessProficiency in Microsoft Word, Excel, and Power Point,EDUCATIONBS degree in life sciences or equivalentFluent in English (written and spoken) We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
BioMarin Pharmaceutical Inc.
Website : http://www.biomarin.com
BioMarin is a world leader in developing and commercializing innovative biopharmaceuticals for rare diseases driven by genetic causes At BioMarin, we focus on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. BioMarin remains steadfast to its original mission—to bring new treatments to market that will make a big impact on small patient populations. These patient populations are mostly children, suffering from diseases so rare, that the entire patient population can number as few as 1,000 people worldwide. These conditions are often inherited, difficult to diagnose, progressively debilitating, have few, if any, treatment options, and are usually ignored. Time is critical to patients with rare diseases, and we strive to quickly develop important therapies for them. The efficiency and speed of our research, development, manufacturing, and commercial efforts is at the heart of our ability to urgently deliver therapies. Our track record of developing and commercializing new treatments has been significantly faster than the industry average and is ingrained in our culture. CenterWatch, a leading source for global clinical trial information, has named it one of the fastest drug developers in the industry. BioMarin was also ranked tenth on Forbes list of innovative companies in 2015. As a biopharmaceutical company, our success stems from our focus on science and the hope our therapies can bring to patients. We are world leaders in metabolic disease innovation with multiple products commercialized and a growing pipeline of product candidates to address unmet medical needs. We continue to fuel our R&D engine by looking for opportunities that align with our strengths and competencies. And we relentlessly pursue exciting, early-stage science that has the potential to change the course of disease. A constant in BioMarin’s culture is how patients continue to drive us. The passion and dedication that our employees bring to work each day is a testament to the inspiration our patients provide, and the knowledge of the impact we can make in their lives.